Itheyiphu ye-fiberglass ye-PTFE idinga izitifiketi ezintathu ezibalulekile zokuphepha: i-UL (ukuphepha kukagesi nelangabi), i-FDA (ukuthobela ukuxhumana nokudla), kanye ne-ISO 9001:2015 (ukuphathwa kwekhwalithi). Amateyipu aqinisekisiwe anikeza ukusebenza okungaguquki, impilo yesevisi ende, nezindleko eziphelele zobunikazi naphezu kwezindleko eziphezulu zangaphambili. Njalo qinisekisa izitifiketi ngokuqondile nezinhlangano ezikhiphayo.

Itheyiphu ye-PTFE yokushisa okuphezulu isetshenziswa kuzo zonke izigaba ezintathu zohlelo lokusebenza lwezokwelapha: ukuvikelwa kwemishini yokuvala inzalo (amathreyi e-autoclave, ukupakishwa kwe-heat-seal), ukwelashwa kwendawo yensimbi (i-low-friction coating, insulation kagesi), kanye namadivayisi afakelwayo (ama-vascular grafts, sutures). I-Biocompatibility iqinisekiswa nge-ISO 10993, futhi i-FDA 21 CFR 177.1550 isungula ukuphepha kwezinto eziyisisekelo.

Itheyiphu yokushisa ephezulu ye-PTFE inokumelana okungekuhle emisebeni ye-ionizing. Ngokuchayeka kwe-gamma engu-1 kGy kuphela, amandla e-tensile ehla aze afike ku-~25% owangempela. Ifaneleka kuphela ezindaweni ezinedosi ephansi (ukuvalwa kokudla/kwezokwelapha <10 kGy). Embonini yenuzi noma imikhumbi-mkhathi, sebenzisa i-polyimide noma i-PEEK esikhundleni salokho.

Kumateyipu e-PTFE aphezulu okushisa ngaphansi kokucwiliswa isikhathi eside, i-PTFE substrate ihlala ingasebenzi ngamakhemikhali, kodwa isendlalelo sokunamathisela iphoyinti elibuthakathaka. Amanzi enza buthaka i-PSA ye-silicone; amanzi anosawoti asheshisa ukugqwala. Kumakhemikhali anolaka, i-fluorosilicone noma i-perfluoropolyether adhesives - noma i-PTFE tape enganamatheli - iyadingeka. Peel ukulahlekelwa amandla kufika ku-40% ngemva kwamahora angu-48 emanzini.

Itheyiphu yezinga lokushisa eliphezulu ye-PTFE esetshenziswa ezinhlelweni zokuxhumana zokudla kufanele ihlale ngaphakathi kwemikhawulo ebekiwe yokushisa: ≤260°C ukuze isetshenziswe ngokuqhubekayo, ≤300°C ngeziqongo ezimfushane (amaminithi), futhi ingalokothi ibe ngaphezu kuka-327°C (ukubola). Imithetho ye-FDA ne-EU ayicacisi umkhawulo wesikhathi ojwayelekile - ubude bokuxhumana obuphephile buncike ezingeni lokushisa futhi kufanele kuqinisekiswe izivivinyo zokufuduka ezilingisa izimo zangempela.

Ukukhetha itheyiphu elungile ye-PTFE yokushisa okuphezulu kombhede oshisayo wephrinta ye-3D kudinga ukugxila ezinkomba ezine ezibalulekile: ukumelana nezinga lokushisa (kufika ku-260°C+), i-fiberglass-reinforced substrate (0.18mm ekahle), i-silicone enamathelayo esekelayo enendawo enganamathele, nobubanzi/ukubekezela okufanele. Lo mhlahlandlela ukusiza ukuthi ugweme ukungqubuzana, izinsalela, nokuhluleka kokuphrinta.

Ukukhethwa kwephepha lokukhishwa noma i-substrate yefilimu kanye ne-ejenti yokukhulula kuthinta ngokuqondile ukuqina kwesitoreji nokusebenza kokuxebuka kwetheyiphu ye-PTFE yokushisa okuphezulu. Lesi sihloko siqhathanisa i-PET vs. kraft paper substrates kanye ne-silicone ngokumelene nama-ejenti okukhululwa e-fluorinated, incoma inhlanganisela efanele yokuxebuka kwezinsalela eziyiziro nokuthembeka kwesikhathi eside.